fromAdalimumab Level for IBD - The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If the steady state trough adalimumab level is low despite adequate dosing, adalimumab anti-drug antibody testing should be considered.
Background: Adalimumab is an established treatment for Crohn's disease. Limited data are available regarding the relationship between adalimumab drug levels and serum/fecal markers of gut inflammation. We therefore aimed to characterize the relationship between adalimumab levels and biologic remission during maintenance therapy.
Methods: A single-center prospective cross-sectional study was undertaken on Crohn's disease patients who had received adalimumab therapy for a minimum of 12 weeks after induction. Data on clinical activity (Harvey-Bradshaw Index), C-reactive protein (CRP), adalimumab drug and antibody levels, and fecal calprotectin were collected. Biologic remission was defined as a CRP <5 mg/L and fecal calprotectin <250 µg/g. Adalimumab drug and antibody levels were processed using the Immundiagnostik monitor enzyme-linked immunosorbent assay.
Results: One hundred fifty-two patients had drug and antibody samples matched with CRP and fecal calprotectin. Patients in biologic remission had significantly higher adalimumab levels compared with others (12.0 µg/mL vs 8.0 µg/mL, P < 0.0001). Receiver operating characteristic curve analysis demonstrated an optimal adalimumab level of >8.5 µg/mL (sensitivity, 82.2%; specificity, 55.7%; likelihood ratio, 1.9) for predicting biologic remission. Multivariable logistic regression revealed that adalimumab levels >8.5 µg/mL were independently associated with biologic remission (odds ratio, 5.27; 95% confidence interval, 2.43-11.44; P < 0.0001).
Conclusions: Higher adalimumab levels are associated with biologic remission. An optimal level of >8.5 µg/mL was identified.
Thank you again for your response! This really makes a lot of sense.Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.
That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.
One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.
Good luck and Keep us posted